Data updated: May 26, 2026
AMTAGVI (lifileucel)
Approved 2024-02-15
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-02-15
- Patent Cliff
- 2036
- Routes
- Intravenous
- Dosage Forms
- Suspension
AMTAGVI Approval History
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Feb 2024 ORIGINAL
Update · CBER biologic (Purple Book)
What AMTAGVI Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2024)
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06151847 | STUDY00150697 NCI-2023-09309, IIT-2022-LDTIL | Ph 2 | completed | Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma |
| NCT06743126 SUPRAME | IMA203-301 | Ph 3 | recruiting | SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma |
| NCT07288203 | IOV-MEL-202 2025-522054-40-00 | Ph 2 | active not recruiting | A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma |
| NCT02360579 LN-144 results posted | C-144-01 | Ph 2 | completed | Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma |
| NCT05176470 | OSU-21202 NCI-2021-11063 | Ph 1 | active not recruiting | Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients |
| NCT06481592 | IOV-END-201 | Ph 2 | recruiting | A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer. |
| NCT03645928 | IOV-COM-202 2018-001608-12, 2024-510779-39-00 | Ph 2 | terminated | Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMTAGVI FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.